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Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work

US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.

Scott Gottlieb and the US FDA came out with the next round of policy documents this week to build on the commissioner's oft-stated missions to help spark innovation in the digital-health space, but at least one of the texts, on clinical-decision-support (CDS) software, is getting some early pushback.

The agency issued a total of two draft and one final guidance document Dec. 7 outline expectations and, in particular, identifying software products that fall outside of FDA requirements for...

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